Musculoskeletal Injury Clinical Trial
Official title:
A Randomized Controlled Trial of Oral Analgesic Utilization for Pain Management of CHildhood Musculoskeletal Injuries
Pain management for children presenting to the emergency department (ED) with an injured
limb is often under-treated, even though it is known that broken arms and legs cause
moderate to severe pain. Further, children are less likely to receive appropriate pain
medicine than adults with similar injuries. This study aims to improve the pain treatment of
children who present to the ED with a suspected fracture, or broken bone or severe sprain.
The investigators will compare the use of 3 different possible medication combinations
(ibuprofen alone, oral morphine alone, or combined ibuprofen and oral morphine) to determine
which combination is the best at treating children's pain. The investigators also plan to
verify the safety of using these different drugs to treat children's pain.
The investigators strongly believe that children's pain should be optimally treated in the
ED. Adequately relieving children's pain is crucial, as inadequate pain treatment can have
both short and longterm effects on the child. It also generates unnecessary stress for both
the child and their caregivers/parents. Given this knowledge, the investigators feel that
their study has the potential to impact care provided in EDs, and improve pain management
safely, for children.
Rationale. Musculoskeletal trauma (MSK-T) in children is very common and almost universally
painful. Standards for children's pain management of MSK-T in the Emergency Department (ED)
vary greatly between Canadian hospitals and, overall, pain is very poorly treated. This
inadequate pain treatment can have significant acute and chronic negative effects. Previous
studies have determined that monotherapy with ibuprofen, the most commonly prescribed oral
analgesic in the ED, is likely providing inadequate pain management for children. In
response to this problem, clinicians have turned back to classic oral opioids (eg morphine)
and are experimenting with combination therapies. To date, few studies have focused on the
efficacy of a combination of a non-steroidal anti-inflammatory drug (NSAID) (eg ibuprofen)
and an opioid (eg morphine). Such a combination of analgesics is known to potentiate pain
relief by blocking it at the level of both the peripheral and the central nervous system. By
combining two drugs with different mechanisms of action, we may be able to provide additive
analgesic effects. To our knowledge, no studies have ever studied the efficacy and safety of
this combination of medication for MSK-T in pediatric EDs. Primary Hypothesis: For children
with a MSK-T in the ED, the addition of morphine to ibuprofen is safe and provides better
pain relief than either of the two drugs alone. Primary Research Question: For children with
a MSK-T in the ED, is a combination of oral morphine (0.2 mg/kg) and oral ibuprofen (10
mg/kg) more efficacious than either of the two drugs, alone, in decreasing pain scores to
<30 mm, 60 minutes after administration?
Methods. Design: This study is a double-blind, placebo-controlled, two center, three-arm,
randomized clinical trial (RCT). Patients will be randomized to receive either: (a)
ibuprofen (10mg/kg) + placebo or (b) morphine (0.2 mg/kg) + placebo or (c) morphine
(0.2mg/kg) + ibuprofen (10mg/kg). Setting: Stollery Children's Hospital (Edmonton, AB) and
CHU Ste.Justine's pediatric hospital (Montreal, PQ). Inclusion criteria: We will include
children: (a) between the ages of 8 and 17 years; (b) visiting the ED with an injured upper
or lower limb that is neither obviously deformed, nor neurovascularly compromised, (c) with
a self-reported pain score >30 mm on a 0 to100mm Visual Analogue Scale (VAS), where 0 mm
corresponds to no pain and 100 mm to the worst pain the child has experienced, and (d) who
understand French or English. Sample Size: Based on previous studies, we expect that between
25-52% (Clark et al., 2007, Le May et al., 2013) of children will achieve a VAS < 30 mm at
60 minutes in the ibuprofen arm. We have conservatively set the proportion of children with
VAS < 30 mm at 60 min to 50%. A sample size of 500 will be then necessary to provide at
least 80% power to detect a 20% absolute difference in proportion using a two-tailed with an
alpha level of 5%. In order to ensure an overall alpha level of 5%, a Bonferroni correction
has been applied in order to take into account the 3 pairwise comparisons that will be
performed. Primary Outcome and Measurement: The primary outcome measure will be pain
intensity score under 30 mm at 60-minutes after medication administration, using the VAS).
Primary Safety Outcomes: We will also assess clinical measures of safety by monitoring
oxygen saturation at 30 minutes intervals, up until 120 minutes. Level of
sedation/alertness, as well as the respiratory rate, of each child will be monitored at set
time points in the study, up until 120 minutes. Participating children will be followed up
(via phone call) at 24 hours, to record any latent side effects or adverse events. Further,
acceptability of the intervention will be assessed.
Relevance: Our proposed work will be the first RCT to investigate if there is some additive
effect of a bi-therapy of pain with ibuprofen and morphine. In summary, currently available
research supports ibuprofen as the monotherapy agent of choice. However, given concerns
regarding its ability to provide adequate relief on its own, smaller studies looked at
morphine as a possible alternative combined to ibuprofen. Very few studies of analgesic
combinations exist, and as such, we have yet to identify the optimal ED pain management
strategy for children with MSK-T. A larger trial with careful control over principal sources
of bias and a rigorous approach to safety data collection will provide clinicians with
strong evidence regarding efficacy and safety on new therapeutic strategies for pain
management related to MSK-T in the pediatric EDs.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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